Depression, TeenNCT04985331
Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents
A study testing W-GenZD in people with Depression, Teen, run by Woebot Health at 1 site in United States.
Trial summary
The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Depression, Teen
- What is being tested?
- W-GenZD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents aged 16-17 years old
- Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
- Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
- Available and committed to engage with the program and complete assessments for an 8-week duration
- Able to read and write in English
- U.S. resident
Show all 9Show fewer
- Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
- If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
- Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
Who cannot join
- Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
- Lifetime diagnosis of bipolar disorder
- Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
- Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
- History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
- Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
- Previous Woebot Application use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.
- Conditions
- Depression, Teen
- Being tested
- W-GenZD
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W-GenZDDevice
W-GenZD is a program that delivers evidence based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent.
| Study group | Role | What they receive |
|---|---|---|
| W-GenZD | Experimental | W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need. Receives: Device: W-GenZD |
| Psychoeducation Control | No intervention | The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-8)
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
Measured: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Secondary outcomes (9)
Generalized Anxiety Disorder (GAD-7)
Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Measured: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Working Alliance Inventory (WAI-SR)
Therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 5-20, with higher scores indicating greater alliance.
Measured: Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks
Mental Health Self-Efficacy Scale (MHSE)
Assesses confidence in managing stress, depression, and anxiety. Range is 10 to 60, with higher scores indicating more self-efficacy.
Measured: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Client Satisfaction Questionnaire (CSQ)
Range from 8 to 32, with higher values indicating higher satisfaction
Measured: Post-treatment (8 weeks from baseline)
Usage Rating Profile Intervention (URPI)
Measurement of feasibility and acceptability. Scores range from 6-36, with higher scores indicating greater feasibility and acceptability.
Measured: Post-treatment (8 weeks from baseline)
Number of active application days
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.
Measured: Post-treatment (8 weeks from baseline)
Number of application messages sent per week
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.
Measured: Post-treatment (8 weeks from baseline)
Satisfaction ratings of psychoeducational materials
Satisfaction metrics in the total number of 'Thumbs up' (likes) or 'Thumbs down' (dislikes) will be collected during the study to provide quantitative data regarding satisfaction with program content.
Measured: Post-treatment (8 weeks from baseline)
Mood change ratings after CBT skill application
Satisfaction metrics in the total number of mood change ratings of 'same', 'better', or 'worse, after learning a CBT skill application will be collected during the study to provide quantitative data regarding satisfaction with content.
Measured: Post-treatment (8 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start2 Aug 2021
- Primary completion16 Dec 2021
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, TeenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985331
- Sponsor's protocol ID
- W-GenZD-002
- Status last verified
- Jan 2022
- First submitted
- 8 Jul 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
- ClinicalTrials.gov ID
- NCT04985331
- Acronym / sponsor ID
- W-GenZD-002
- Conditions
- Depression, Teen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W-GenZD | Experimental | Device: W-GenZDW-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need. |
| Psychoeducation Control | No intervention | –The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills. |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Adolescents aged 16-17 years old
- Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
- Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
- Available and committed to engage with the program and complete assessments for an 8-week duration
- Able to read and write in English
Key exclusion criteria (7 listed)
- Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
- Lifetime diagnosis of bipolar disorder
- Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
- Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
- History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| W-GenZDW-GenZD is a program that delivers evidence based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent. | Device | W-GenZD |
Primary outcome
Patient Health Questionnaire (PHQ-8)
Time frame: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
9 secondary outcomes
Generalized Anxiety Disorder (GAD-7)
Time frame: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Working Alliance Inventory (WAI-SR)
Time frame: Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks
Mental Health Self-Efficacy Scale (MHSE)
Time frame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Client Satisfaction Questionnaire (CSQ)
Time frame: Post-treatment (8 weeks from baseline)
Usage Rating Profile Intervention (URPI)
Time frame: Post-treatment (8 weeks from baseline)
Number of active application days
Time frame: Post-treatment (8 weeks from baseline)
Number of application messages sent per week
Time frame: Post-treatment (8 weeks from baseline)
Satisfaction ratings of psychoeducational materials
Time frame: Post-treatment (8 weeks from baseline)
Mood change ratings after CBT skill application
Time frame: Post-treatment (8 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W-GenZD in people with Depression, Teen, run by Woebot Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-8) (time frame: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.